MoFo Life Sciences

October 04, 2022 - FDA, Product Liability + Class Action
Water Is in, White Bread Is Out: “Healthy” Gets a New Look in 2023
By: Claudia M. Vetesi, Lena Gankin and Nick R. Dyess
For decades, health-conscious consumers have argued about what it really means for a food to be “healthy.” Is dark chocolate “healthy”? How about breakfast cereal, coffee, or fruit gummies? At the same time, class action litigants have seized on ever-evolving and subjective definitions of “healthy,” pursuing claims
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April 13, 2022 - FDA, Product Liability + Class Action, Litigation, Regulatory
RULINGS, FDA GUIDANCE MAY HELP FOOD COS. IN PROTEIN SUITS
By: Claudia M. Vetesi, Nicole Victoria Ozeran and Lena Gankin
Originally published by Law360 , Claudia Vetesi, Nicole Ozeran, and Lena Gankin authored an article discussing a wave of protein-labeling lawsuits hitting food manufacturers, alleging that their products’ front-label protein content statements violate U.S. Food and Drug Administration (FDA) regulations, and mislead consumers by overstating the amount
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December 30, 2020 - FDA, COVID-19, Product Liability + Class Action
FDA’s Covid-19 Product Regulation Enforcement Roadmap
By: Erin M. Bosman and Julie Y. Park
Navigating FDA’s regulatory enforcement strategies is paramount to successfully marketing health and medical products for COVID‑19—especially since the pandemic has dominated FDA’s enforcement activity this year. Understanding the patterns and principles behind FDA’s efforts can provide the insight product manufacturers need to avoid FDA
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September 18, 2020 - United States, FDA, COVID-19, Product Liability + Class Action, Healthcare
First Decisions Limit PREP Act Immunity in Coronavirus Context
By: Erin M. Bosman and Julie Y. Park
When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure manufacturers and distributors of novel COVID-19 drugs and medical products. So far, so good: the first court decisions interpreting PREP Act
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June 08, 2020 - FDA, COVID-19, Product Liability + Class Action
How FDA Is Monitoring the COVID-19 Product Market
By: Erin M. Bosman and Julie Y. Park
FDA is actively “monitor[ing] the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic.” The agency says it has discovered hundreds of fraudulent COVID-19 products, including drugs, test kits, and PPE sold online with unproven claims. It is working
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May 26, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action, Healthcare
FDA Signals Flexibility with COVID-19 Tests
By: Erin M. Bosman and Julie Y. Park
A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 million per day by midsummer—in order to fully re-mobilize the economy. Consistent with this, FDA has taken various steps
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May 08, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action
COVID-19 Alert: FDA updates antibody test policy
By: Erin M. Bosman and Julie Y. Park
Serology tests could play a critical role in the fight against COVID-19. Serology tests may help determine who can donate convalescent plasma—a part of the blood containing antibodies—which is currently being explored as an investigational treatment for those with COVID-19. Convalescent plasma has been
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May 01, 2020 - United States, FDA, COVID-19, Product Liability + Class Action
COVID-19 UPDATE: FDA AUTHORIZES FIRST AT-HOME COLLECTION KIT
By: Erin M. Bosman and Julie Y. Park
FDA has been actively working to accelerate access to diagnostic tests for COVID-19 through its extension of Emergency Use Authorizations (EUAs). According to FDA Commissioner Stephen M. Hahn, M.D., “The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more
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April 22, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action, Biotech, Healthcare, Pharma
FDA Uses EUAs Broadly In The Fight Against Covid-19
By: Julie Y. Park
On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a significant potential for a public health emergency related to the novel
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April 21, 2020 - FDA, COVID-19, Product Liability + Class Action, Healthcare
HHS Guidance Broadens PREP Act Immunity, Tightens Focus on Public/Private Cooperation
By: Erin M. Bosman and Julie Y. Park
On April 14, the U.S. Department of Health and Human Services (HHS) issued an advisory opinion on the Public Readiness and Emergency Preparedness (PREP) Act to clarify the scope of immunity that accompanies developing and deploying countermeasures to COVID-19. The PREP Act grants tort
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Topic Archives: Product Liability + Class Action

Water Is in, White Bread Is Out: “Healthy” Gets a New Look in 2023

By: Claudia M. Vetesi, Lena Gankin and Nick R. Dyess

RULINGS, FDA GUIDANCE MAY HELP FOOD COS. IN PROTEIN SUITS

By: Claudia M. Vetesi, Nicole Victoria Ozeran and Lena Gankin

FDA’s Covid-19 Product Regulation Enforcement Roadmap

By: Erin M. Bosman and Julie Y. Park

First Decisions Limit PREP Act Immunity in Coronavirus Context

By: Erin M. Bosman and Julie Y. Park

How FDA Is Monitoring the COVID-19 Product Market

By: Erin M. Bosman and Julie Y. Park

FDA Signals Flexibility with COVID-19 Tests

By: Erin M. Bosman and Julie Y. Park

COVID-19 Alert: FDA updates antibody test policy

By: Erin M. Bosman and Julie Y. Park

COVID-19 UPDATE: FDA AUTHORIZES FIRST AT-HOME COLLECTION KIT

By: Erin M. Bosman and Julie Y. Park

FDA Uses EUAs Broadly In The Fight Against Covid-19

By: Julie Y. Park

HHS Guidance Broadens PREP Act Immunity, Tightens Focus on Public/Private Cooperation

By: Erin M. Bosman and Julie Y. Park